GETTINGE_Sole_Source.doc

Justification For Non-Competitive Procurement Getinge Service Maintenance Agreement Authority Cited: FAR 13.106-1 (b) (1)

MEMORANDUM

From: Jack Paar To: Contracting Officer Date: May 26, 2015 Description of Requirement: This is a service maintenance agreement (SMA) purchase order to provide all necessary parts, and labor expenses for preventive and emergency remedial service on the Getinge 422LS Autoclaves, including Steam Sterilization units ( SN 02L03487 & 05H06239) and Boilers (SN GC31468X2202 and GC32091005), location: Room 206, as well as HS-200 WATTS Watts RO Systems (SN’s: 05200508 and 05200509, location: Service Corridor 4, USEPA New England Regional Laboratory, Chelmsford, MA (NERL, Region 1). Service maintenance agreements are an essential component of quality control (QC) and quality assurance (QA) of analytical data. Routine service maintenance will insure proper operation of the Getinge Autoclaves and minimal interruption of the instruments and their use. The Getinge USA, Inc. 400LS series steam sterilizers, boilers, and RO water systems function as a unit and are instruments that utilize water and high voltage electricity to produce high pressure steam used to sterilize laboratory materials and infectious laboratory waste. The dangerous nature of water, high voltage electricity, steam, and infectious material make it imperative that these instruments are serviced, maintained, and operated by properly qualified and trained individuals working in a safe manner and the proprietary nature of the instrumentation and support software make it imperative that these instruments are serviced, maintained, and operated by properly qualified and trained individuals working in a safe manner.

NERL Region 1 must sterilize and or disinfect thousands of samples annually. In order to maintain confidence in the safety of lab personnel and service technicians NERL, Region 1 Quality Assurance procedures require routine maintenance of these instruments as well as a service maintenance agreement (SMA) in place for emergency repairs as needed. This SMA will provide the laboratory with licensed software and documentation updates, 800 support number, access to a technical service representative for troubleshooting, quarterly preventive maintenance, and resolution to technical problems through on-site service maintenance should they arise. EPA Plans to initiate service contact from 10/01/2016 to 09/30/2017 with four (4) option follow-on years.

Justification for sole source request (only one source reasonably available): This unique Getinge instrumentation and associated unique software are proprietary in nature and Getinge is the sole source for technical service and/or repair, parts, and software upgrades. If, for any reason, the SMA with Getinge is discontinued or SMA support lapses there would be a severe negative impact to USEPA program offices such as ORD, OWOW, OST, and programs clients such as Superfund, Clean Water Act, States and Tribes; Negative impact resulting from substantial increased costs as extra funding would be required for reinstatement and unacceptable delays for non-SMA scheduled repairs and/or recalibration to the extent that delays could compromise laboratory staff and/or public health safety and sampling programs would need to be halted or discontinued due to the inability to sterilize or disinfect samples.

Absence of a SMA for the Getinge 422LS Autoclaves, boilers and Watts RO water systems would adversely impact analytical results and research products for which NERL, Region 1 is responsible.